CELLACTOR® - Equipment for the extracorporeal induced shock - Storz Medical AG

Duns Number:481967776

Device Description: Equipment for the extracorporeal induced shock and pressure wave therapy for stationary an Equipment for the extracorporeal induced shock and pressure wave therapy for stationary and mobile use.

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More Product Details

Catalog Number

-

Brand Name

CELLACTOR®

Version/Model Number

SC1 T-Top blue

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ISA

Product Code Name

Massager, Therapeutic, Electric

Device Record Status

Public Device Record Key

9f2ef82f-039d-4655-8a50-129f4932a52c

Public Version Date

August 20, 2020

Public Version Number

5

DI Record Publish Date

August 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STORZ MEDICAL AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 11
3 A medical device with high risk that requires premarket approval 7